Sr Product Process and Design Engineer (Instrument Mfg)
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Job Description
Summary of company: This role is for our sister company - Mainline Scientific is a Malvern, Pennsylvania-based bioanalytical technology company, focusing on developing and manufacturing robust and innovative life science instrumentations.
Title: Sr Manufacturing Engineer
Department: Manufacturing
Location: Malvern, PA
Supervisory Responsibility: No
FLSA Status: Exempt
Position Type: Full - time
Travel Required: Yes, occasionally
Expected Hours of Work: 40 hours a week M-F 9-5 in office
Summary/Objective
We are seeking a skilled and motivated Sr Manufacturing Engineer to join our team in supporting the production of advanced analytical instruments. In this role, you will work closely with R&D engineers to bridge product design and manufacturing, playing a key role in process development, production line setup, and continuous improvement initiatives. This position is ideal for someone who is hands-on, detail-oriented, and passionate about quality, efficiency, and innovation in manufacturing.
Description
Essential Duties and Responsibilities
- Collaborate with R&D engineers to design and develop scalable and robust manufacturing processes.
- Design, establish, and optimize production lines for new and existing analytical instruments.
- Develop and implement product packaging solutions to ensure protection, compliance, and efficient logistics.
- Lead the qualification and validation of manufacturing processes to meet regulatory and quality standards.
- Plan, coordinate, and support product builds, from prototyping through to full-scale production.
- Monitor and drive improvements in production yield, efficiency, and product quality.
- Identify and implement continuous improvements in products and processes for enhanced quality, reduced cost, and improved delivery performance.
Requirements
Qualifications Requirements
- ~2+ years of relevant experience in manufacturing engineering, preferably in the instrumentation or high-tech equipment sector.
- Strong problem-solving skills with a hands-on approach to engineering challenges.
- Familiar with ISO9001 QMS
- Experience with production line setup, process qualification, and continuous improvement tools (e.g., Lean, Six Sigma) is a plus.
- Excellent communication and collaboration skills, with the ability to work effectively across cross-functional teams.
Preferred Skills:
- Familiar with ISO13485 or 21CFR820 Quality Management System for Medical Device
- Prior design or development experience for analytical instruments or medical devices.
- Hands-on experience in prototyping, soldering, and debugging
Education, License, Certification, or Preferred Qualifications
- Bachelor’s degree in Engineering or a related STEM discipline (e.g., Mechanical, Electrical, Industrial, or Manufacturing Engineering).
Tools and Technology Used
- Microsoft Office 365 (Word, Excel, PowerPoint, Teams, Outlook…)
Work Environment & Mental and Physical Requirements
- Ability to remain in a stationary position; move; operate and use required equipment; and reach items.
- Ability to move/transport up to 30 lbs., and up to 50 lbs. occasionally.
- Ability to communicate, converse with others, and exchange information
Benefits
Medical (HMO + PPO), Dental, Vision, & employer-paid Basic Life/AD&D + ST Disability
4% Match 401k
PTO: 15 days (vacation/personal days) + 5 sick days + holidays